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ZOLL AED 3 complies with the MDR

ZOLL AED 3 complies with the MDR

The ZOLL AED 3 defibrillators meet the strict requirements of the Medical Devices Regulation (MDR). ZOLL is one of the first manufacturers to obtain CE certification according to the MDR.

View the ZOLL AED 3 semi-automatic or fully automatic.

ZOLL is also actively working to obtain EU MDR approval for the ZOLL AED Plus, Powerheart G5 AED and ZOLL electrodes.

What is the MDR?

The MDR (Medical Device Regulation) sets new, stricter requirements for medical devices sold in Europe. This law has been in force since May 26, 2021. Manufacturers have until May 26, 2024 to request a reassessment under the MDR for any medical device. To this end, they must, among other things, update their quality management system and technical documentation.

After inspection, an 'extended MDD certificate' is first issued. This allows the manufacturer to continue selling the device in question after May 26, 2024. The MDD certificate is valid until the official MDR certification is issued.

Read more about the MDR


April 4, 2024

 
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